eSTAR is voluntary for De Novo requests, but not being accepted for Premarket Approval Applications (PMAs) in CBER yet. De Novo, Pre-Sub submissions, and certain PMA application and supplements can be voluntarily submitted as eSTAR through the CDRH Portal or mailed to the FDA. Per draft guidance Electronic Submission Template for Medical Device De Novo Requests FDA should announce the specific requirement for these electronic submissions sometime around September 20, 2025, but there will be a transition period between the final guidance and implementation. I hope this helps.
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Juliane Carvalho RAC, MSc
Lead Regulatory Health Project Manager at CBER - OTP
US Food and Drug Administration
United States
**My comments are an informal communication and represent my own best judgement. These comments do not bind or obligate the U.S. Food and Drug Administration**
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Original Message:
Sent: 29-Feb-2024 11:41
From: Beth Lentz
Subject: eSTAR PMA and De Novo submissions
Hello regulatory community - has anyone heard any updates from the FDA regarding implementation of use for eSTAR De Novo, Pre-Sub or PMA submissions? I know they are both still voluntary last check on the FDA website this week.
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Beth Lentz
RIMSYS
Pittsburgh PA
United States
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